Senior Quality Engineer

Katalyst-Healthcares-; Cincinnati (OH); Presencial; USD 110.000 - 140.000; Jornada completa

Descripción de la vacante

Katalyst-Healthcares- is seeking an experienced Senior Quality Engineer focused on medical devices to lead quality activities across development, design controls, transfers, and sustaining operations.

The role emphasizes risk management, V&V, CAPA, and regulatory compliance with FDA and ISO standards. A strong background in Class II/III devices and cross-functional collaboration is required.

Formación

• 8+ years of quality engineering experience in the medical device industry.
• Experience supporting Class II and Class III medical device development and manufacturing.
• Hands-on experience with design controls, risk management, and product development quality activities.
• Experience supporting FDA and ISO audits and regulatory inspections.

Responsabilidades

• Develop, review, and approve quality plans, product specifications, engineering changes, and development deliverables.
• Lead design control activities in compliance with FDA and ISO requirements.
• Develop and maintain risk management documentation (DFMEAs, PFMEAs, ISO 14971).
• Review and approve Design Verification and Validation (V&V) protocols and reports.
• Support equipment and manufacturing process validation (IQ/OQ/PQ).
• Lead investigations into nonconformances and deviations; drive CAPA.
• Perform root cause analysis using structured methodologies.
• Apply statistical techniques for process capability studies and MSA.
• Develop and update SOPs, work instructions, and quality-system documentation.
• Support internal and regulatory audits; contribute to post-market surveillance and complaint analysis.
• Collaborate with cross-functional teams for manufacturing transfers, new launches, and sustaining engineering activities.

Conocimientos

Quality Engineering

FDA/ISO regulatory

CAPA & RCA

DFMEA / PFMEA

V&V protocols

Risk Management (ISO 14971)

Statistical methods (MSA, SPC)

Cross-functional collaboration

Educación

Bachelor's degree in Engineering

Master's degree preferred

Descripción del empleo

Job Summary

We are seeking an experienced Senior Quality Engineer – Medical Devices to lead and support quality engineering activities across medical device product development, design controls, manufacturing technical transfers, and sustaining operations.

Roles and Responsibilities

• Develop, review, and approve quality plans, product specifications, engineering changes, and product development deliverables.
• Lead and maintain design control activities in accordance with FDA and ISO regulatory requirements.
• Develop, review, and maintain risk management documentation, including DFMEAs, PFMEAs, and risk management reports, in compliance with ISO 14971.
• Review and approve Design Verification and Validation (V&V) protocols, reports, and related documentation.
• Support equipment and manufacturing process validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Lead investigations into product nonconformances, process deviations, and quality-related issues.
• Drive Corrective and Preventive Actions (CAPA) and conduct structured Root Cause Analysis (RCA) using appropriate problem-solving methodologies.
• Apply statistical techniques for process capability studies, sampling plans, Measurement System Analysis (MSA), and process improvement initiatives.
• Develop, review, and update Standard Operating Procedures (SOPs), work instructions, and other quality-system documentation.
• Support internal, external, and regulatory audits, ensuring compliance with FDA and ISO requirements.
• Support post-market surveillance activities, complaint investigations, and complaint-trend analysis.
• Collaborate with cross-functional teams to support manufacturing technical transfers, product launches, and sustaining engineering activities.

Education & Experience

• Bachelor's degree in engineering, Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Manufacturing Engineering, or a related technical discipline.
• Master's degree in engineering, Biomedical Engineering, or a related field is preferred.
• Minimum 8+ years of experience in Quality Engineering within the medical device industry.
• Strong experience supporting Class II and Class III medical device development and manufacturing.
• Hands-on experience with design controls, risk management, and product development quality activities.